Study to Develop a Reliable Nomogram That Incorporates Clinical and Genetic Information
Status:
Completed
Trial end date:
2011-06-01
Target enrollment:
Participant gender:
Summary
In this research study, the investigators are trying to find a better way to set the dose of
a common blood-thinning medication.
Patients with blood clots or a risk of blood clots (or stroke) sometimes have to take an
approved medication called warfarin. Warfarin is a commonly prescribed, approved blood
thinning medicine taken by mouth. There is a certain level of warfarin that is best for each
patient at a particular time. It is hard for a doctor to choose and maintain the right dose
of warfarin for each patient. Too much or too little warfarin in the blood can cause serious
health problems.
A "nomogram" is a tool that helps doctors decide on the right dose of warfarin. The usual way
for finding the right dose of warfarin is for doctors to take an educated guess and use a
"trial and error" approach. Patients have frequent blood tests to help doctors keep track of
how well the dose level is working.
Up until now, if a patient had good blood test results over half of the time, that was as
well as doctors could do. The purpose of this study is to see whether the investigators can
create a reliable new warfarin nomogram that will allow them to dose a patient correctly more
often, perhaps about 3 times out of 4. The nomogram the investigators are studying uses
information about a patient's health and genes to decide on the best dose of warfarin.
The investigators don't yet have a reliable, safe way to choose the correct dose. In this
study, the investigators will use a genetic blood test to try to find a better way. Genes are
the parts of each living cell that allow characteristics to be passed on from parents to
children. The investigators know that people with certain genes seem to respond to warfarin
in a certain way. From a blood sample, the investigators can look at patients' genes and try
to predict the response to the blood-thinning medication.
There will be about 500 subjects taking part in this study. They will come from participating
Partners' Hospitals, including Brigham and Women's Hospital, Massachusetts General Hospital,
Faulkner Hospital, Newton-Wellesley Hospital, Spaulding Rehabilitation Hospital, and North
Shore Medical Center. The U.S. Food and Drug Administration (FDA) has approved warfarin for
use as a blood thinner.
Phase:
N/A
Details
Lead Sponsor:
Brigham and Women's Hospital
Collaborators:
Massachusetts General Hospital Newton-Wellesley Hospital Spaulding Rehabilitation Hospital